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New York State Department of Health Petition Leads to FDA Changes to Nicotine Replacement Therapy Packaging and Marketing

New FDA Guidelines Will Support Smokers' Efforts to Quit

Albany, N.Y, (May 24, 2013) – State Health Commissioner Nirav R. Shah, M.D., M.P.H., today announced that the U.S. Food and Drug Administration (FDA) has responded favorably to a petition submitted by the New York State Department of Health (DOH) that is designed to make it easier for smokers to quit.

In 2008, DOH became the first state health department in the nation to petition the FDA to relax restrictions on the sale of over-the-counter Nicotine Replacement Therapy (NRT) products such as patches, gum and lozenges in order to help more smokers quit successfully. Last month, the FDA responded to New York's petition, along with petitions from other public health organizations, agreeing to allow the sale of over-the-counter NRT in all retail outlets where cigarettes are sold, and also allowing consumers to purchase these products in smaller package sizes. Together, these changes will make it more convenient and affordable for consumers to use NRT to quit smoking.

"Despite common knowledge about the health risks of tobacco, quitting smoking is often a difficult process and many smokers struggle to succeed," Commissioner Shah said. "Nicotine Replacement Therapy has proven to be an effective tool to help smokers quit. By making it available at local retail stores where tobacco products are sold, we hope to increase the number of smokers whose attempts to quit are successful."

A driving force behind DOH's petition is that most smokers actually want to quit. Surveys conducted by DOH in 2012 showed that 75 percent of the 2.7 million adult smokers in New York want to quit smoking "somewhat" or "a lot," but few actually succeed.

The Clinical Practice Guideline for Treating Tobacco Use and Dependence recommends NRT, with or without additional support or counseling, as a proven strategy that increases the likelihood that smokers will be able to quit successfully. However, many smokers do not use NRT when they make a quit attempt due to factors including:

Cigarettes and other tobacco products remain widely accessible in retail outlets in communities across New York, yet federal policy has tightly controlled access to the safest forms of nicotine therapies, such as patches, gum and lozenges.

There are nearly 20,000 licensed tobacco retailers statewide (approximately one retailer for every 135 smokers), which provide smokers with easy access to highly addictive and deadly tobacco products, such as cigarettes. Prior to the FDA's decision, certain types of stores, including neighborhood convenience stores and gas stations, however, were prohibited from selling NRT.

NRT has been sold only in large package sizes that are much more expensive than the price of a pack of cigarettes. Under the system in place prior to the FDA's decision, NRT had to be purchased in a minimum of a one- or two-week supply that cost $20 to $50. Since a pack of cigarettes or other tobacco products were available at a significantly lower price, many consumers chose not to make the investment to stop smoking.

Many smokers are also confused about the safety of NRT, mistakenly believing that these nicotine products can cause cancer, or that patches or gum are more likely than cigarettes to cause a heart attack. In reality, it is the toxic smoke from cigarettes, not the nicotine, that causes a long list of diseases including various types of cancers, heart disease, stroke and emphysema. FDA is allowing changes to the labeling of NRT that help clarify its safety, especially when compared with the health risks of continued cigarette smoking.

Widespread availability of NRT also will increase smokers' familiarity with these products, which is expected to increase their use. It has been shown that smokers who combine the use of NRT with physician consultations and/or use of the New York State Smokers' Quitline (1-866-NY-QUITS), dramatically increase their chances of successfully defeating their addiction. When NRT is combined with counseling, the chances of successful quitting increase by 40 percent over medication alone and by 70 percent over counseling alone.

Tobacco use continues to be the number one cause of preventable death in New York State and nationally, killing more than 400,000 Americans and costing the nation $96 billion in health care costs each year.